Trevi Therapeutics, Inc. Q4 FY2024 earnings call

• Jennifer Good highlighted strong execution in 2024 with three positive data readouts: Human Abuse Potential study, Sample Size Re-Estimation, CORAL study in IPF chronic cough, and RIVER study in RCC. Discussed progress in clinical trials, timelines for future data releases, and plans for FDA meetings.
• Lisa Delfini reviewed financial results, cash position, noting $107.6 million in cash as of Dec 31, 2024, and provided cash runway guidance into the second half of 2026, expecting cash burn of $12-14 million per quarter in Q1 and Q2 2025.

For the fourth quarter of 2024, Trevi Therapeutics reported a net loss of $11.4 million compared to $7.8 million in the same quarter of 2023. R&D expenses were $9.3 million in Q4 2024 vs $6.5 million in Q4 2023, primarily due to increased clinical trial costs. G&A expenses increased to $2.9 million in Q4 2024 vs $2.4 million in Q4 2023, mainly from stock-based compensation and personnel costs. As of December 31, 2024, cash, cash equivalents, and marketable securities totaled $107.6 million, including a $50 million offering completed in December.

• Cash runway into the second half of 2026 remains unchanged, funding ongoing Phase 2b CORAL trial and next RCC trial.
• Expect cash burn net of interest income of about $12 million to $14 million per quarter in Q1 and Q2 2025.
• Will provide additional cash burn guidance as they get FDA feedback and plan subsequent trials.

Q: Faisal Khurshid asked about patients enrolled in CORAL and discontinuation rate.

A: Jennifer Good responded that enrollment was almost 75-80% when SSRE results were received, and discontinuation rate stayed in single-digits throughout the study.

Q: Mayank Mamtani asked about placebo response expectation for IPF study and baseline cough counts.

A: Jennifer Good discussed placebo effect assumptions (30% placebo, 66% drug effect) and noted baseline cough counts are being monitored by medical team but no specific commentary on differences from CANAL.

Q: Mayank Mamtani asked about RCC patient population split.

A: Jennifer Good stated they are targeting treatment failure patients, with P2X3 therapies potentially being first-line, and Haduvio for second or third-line.

Q: Annabel Samimy asked about efficacy maxing out, dosing in CORAL, and AEs.

A: Jennifer Good mentioned CORAL results show effective dose in 27-54 range, planning for lower dosing to improve AEs and flexibility.

Q: Leland Gershell asked about timelines and route-to-market.

A: Jennifer Good talked about regulatory strategy (IPF NDA first, RCC as SNDA), and using safety data from prior programs for route-to-market.

Q: Serge Belanger asked about respiratory physiology study.

A: Jennifer Good said the study is underway, with some operational adjustments and Jim contemplating dose adjustments.

Q: Ryan Deschner asked about exploratory metrics and stratification in RCC.

A: Jennifer Good stated no stratification planned for RCC studies as efficacy was strong across moderate and severe coughers.

Q: Brandon Folkes asked about placebo rates in IPF vs RCC.

A: Jennifer Good attributed differences to study center differences (IPF in more normal centers, RCC in high-end cost centers).

Q: Christian Cubides asked about secondary endpoints for prescriptions.

A: Jennifer Good mentioned patient secondary endpoints and quality-of-life metrics will be important for payer resistance.